Associations Between the Oral and Intestinal Microbiome and Neovascular Age-related Macular Degeneration

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: intravitreal Anti-VEGF injection; Drug: Probiotic Combination Cap/Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT05604989

AMDMICROBIOME

Details and patient eligibility

About

A pilot study for Associations between the oral and intestinal microbiome and neovascular age-related macular degeneration and the investigation on the effect of oral probiotics as a treatment

The investigators recruit the neovascular AMD patients and control patients.

1. 15 neovascular AMD patients with anti-VEGF treatment and oral probiotics supplement
2. 15 neovascular AMD patients with anti-VEGF treatment and no oral probiotics supplement
3. 15 control patients and no oral probiotics supplement

The investigators will collect stool, blood, and saliva sample at the baseline and 6 months, and analyze the oral and intestinal microbiome changes.

Enrollment: 45 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal BMI patients
• Diagnosed as neovascular AMD (experimental & sham group)
• Normal patients (control group)

Exclusion criteria

• Obese (BMI > 30)
• Past surgical history involving intestinal diseases
• Previous oral antibiotic treatment before 1 week at the baseline enroll
• Previous oral probiotics supplement
• Previous ophthalmic retinal diseases except neovascular AMD

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

45 participants in 3 patient groups

Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement

Experimental group

Description:

Neovascular AMD patients will be allocated. Regular intravitreal anti-VEGF injection treatment will be done. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis. Oral probiotics (The Perfect Probiotics®) supplement will be given to the participants for 6 months.

Treatment:

Drug: Probiotic Combination Cap/Tab

Drug: intravitreal Anti-VEGF injection

neovascular AMD patients with anti-VEGF treatment, no oral probiotics supplement

Sham Comparator group

Description:

Neovascular AMD patients will be allocated. Regular intravitreal anti-VEGF injection treatment will be done. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis. No Oral probiotics (The Perfect Probiotics®) supplement in this group.

Treatment:

Drug: intravitreal Anti-VEGF injection

Control patients, no oral probiotics supplement

No Intervention group

Description:

Healthy, no retinal disease patients will be allocated. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis. No Oral probiotics (The Perfect Probiotics®) supplement in this group.